The objective of the study is to develop a biorepository from patients with extreme metformin intolerance to assess predictive biomarkers (clinical, genetic and genomic) of intolerance.
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
- Diabetic complications
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
First a biorepository containing genetic profiles, biochemical and clinical
characteristics of the patients will be constructed. This biorepository will be
used to identify predictive biomarkers (clinical, genetic and genomic) of
metformin intolerance.
Secondary outcome
Not applicable.
Background summary
There is considerable variability in who gets gastrointestinal side effects
with metformin treatment. About one quarter of patients experience
gastrointestinal side effects that are mild or self-limiting, but 1 in 20 have
such severe side effects that they are unable to tolerate any dose or just a
low dose (500mg). The aim of this study is to collect a cohort of patients who
have such extreme intolerance and identify predictive genetic and metabolic
biomarkers for intolerance. This study is part of a wider study taking place
in our centre and other centres in the UK, Denmark, Sweden and Germany as part
of the European union-funded IMI-DIRECT consortium. DNA, serum, plasma and
urine will be pseudonymized and collected in a biorepository for comparison
with a group of metformin tolerant patients (prescribed >= 2g metformin for more
than 6 months) from the same centre who are participating in another study and
from centres within the DIRECT consortium.
Study objective
The objective of the study is to develop a biorepository from patients with
extreme metformin intolerance to assess predictive biomarkers (clinical,
genetic and genomic) of intolerance.
Study design
Observational cohort study
Study burden and risks
Before the annual check-up at the DCS screening questions will be sent to the
participants or asked by phone to confirm severe metformin intolerance in the
past, informed consent to use data from medical records and the donation of
blood and urine will be taken. A donation of a blood sample (30 ml) and one
urine sample (5 ml) will be asked of the subjects. Because this will be done
during one of the regular visits, the risk as well as the burden for the
subjects is negligible. The donated blood and urine samples will be
pseudo-anonymized, collected in a biorepository and analysed (e.g. DNA
profiling and metabolomics) when the cohort is complete. Benefit for the
subjects will be the identification of risk factors for metformin intolerance,
which may facilitate the development of better treatment.
van der Boechorststraat 7
Amsterdam 1081 BT
NL
van der Boechorststraat 7
Amsterdam 1081 BT
NL
Listed location countries
Age
Inclusion criteria
Written informed consent
Patients with Type 2 diabetes
White European
Potential metformin intolerance
Exclusion criteria
- Type 1 diabetes
- Age at study start <18 or >90
- Inability to consent
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL43631.029.13 |